CONTACT-K APTT REAGENT

Plasma, Coagulation Control

PACIFIC HEMOSTASIS

The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Contact-k Aptt Reagent.

Pre-market Notification Details

Device IDK834086
510k NumberK834086
Device Name:CONTACT-K APTT REAGENT
ClassificationPlasma, Coagulation Control
Applicant PACIFIC HEMOSTASIS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGGN  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-28
Decision Date1984-02-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00845275000658 K834086 000
00845275000634 K834086 000

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